BEUDAMED
    FDA Recall Terminated

    SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas

    Recall: Z-0880-05 · Initiated July 1, 2002

    Recall

    Recall Number
    Z-0880-05
    Event Number
    30399
    Firm
    Spinal Concepts, Inc
    FEI Number
    3000718496
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 1, 2002
    Posted
    June 11, 2005
    Terminated
    December 20, 2005
    Address
    5301 Riata Park Ct, Bldg F, Austin, TX, 78727-3436

    Description

    SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas

    Reason

    Complaints were recieved where swivels came out of plate and where the screw went through the plate.

    Action

    The firm initiated the recall via telephone communication from sales representatives around August 2002.

    Distribution

    Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA

    Quantity

    10 systems